Bill would allow compounding with no prescription

Apr. 4, 2013

Sen. Ferrell Haile, R-Gallatin, is a pharmacist.

Written by

Walter F. Roche Jr. and Tom Wilemon

The Tennessean

The Tennessee Senate on Thursday overwhelmingly approved a measure that would allow pharmacists to compound drugs without having a prescription for a specific patient, a key safeguard that exists under current law.

The measure was approved on a 29-1 vote, without a word of dissent, after a presentation by Sen. Ferrell Haile, R-Gallatin, who is a pharmacist. Sen. Todd Gardenhire, R-Chattanooga, cast the only vote against the bill.

A House version of the bill, sponsored by Rep David Shepard, a Dickson Democrat, has cleared the House Health Committee and is awaiting a House floor vote. Shepard, like Haile, is a pharmacist.

The Tennessee Pharmacists Association pushed for adoption of the bill, which would create a loophole for hospitals and other health care providers to obtain compound drugs without having to identify a patient. It would do so by permitting compounders to ship drugs without having received a patient-specific prescription in cases when a product “is not commercially available.”

“This has nothing to do with what happened in Massachusetts,” Haile said during a brief discussion before the vote.

Massachusetts-based New England Compounding Center made the medicine linked to the fungal meningitis outbreak that was discovered in Nashville last year. It shipped large quantities of a contaminated drug without patient-specific prescriptions, which was a violation of its operating license, and failed to maintain sterility safeguards, according to government regulators.

Haile made the argument that drug shortages also loom as a major public health threat. Citing “a grave drug shortage,” he said the measure would allow pharmacists to compound life-saving drugs in advance.

“It is not possible to know the name of the patient before the medical event occurs,” Haile said, “but the providers do know the drugs they need.”

Patient safety advocates said the bill puts the public at risk.

“The bill will undermine patient safety in Tennessee and represents a substantial step in the wrong direction in the wake of the fungal meningitis outbreak,” said Dr. Michael Carome, who heads drug safety initiatives for Public Citizen. “It would legalize in Tennessee the large-scale production of drugs that have not been approved by the FDA nor manufactured according to the high safety and quality standards that patients in this country expect.

“Violation of the federal standards for ensuring the safety and quality of drugs led to the ongoing fungal meningitis disaster, and this bill, if enacted will guarantee similar events in the future.”

Diana Zuckerman, the president of the National Research Center for Women & Families, also criticized the bill.

“It is not possible to solve the problem of unsafe pharmaceuticals by allowing the continued widespread sale of pharmaceuticals that are not proven safe and effective,” Zuckerman said. “Unfortunately, this bill would have that effect.”

Law not enforced

Tennessee has not enforced its patient-specific prescription requirement. If it had, persistent drug shortages would have been worse, according to Baeteena Black, executive director of the Tennessee Pharmacists Association.

But the diligence of other states protected their residents from the fungal meningitis outbreak. New England Compounding Center was able to mass-produce medicine and then ship the drugs to states that either didn’t have the requirement or didn’t enforce it. No one got sick in Colorado because that state stopped the company from shipping drugs there in 2011 after discovering it wasn’t abiding by the prescription requirement.

The Senate’s bill has other provisions. It would require out-of-state compounders to provide a copy of their most recent inspection survey to the Tennessee Board of Pharmacy. The survey would have to have been conducted within a year for Tennessee to renew an out-of-state compounder’s license to do business in this state.

Those compounders also would be required to report to Tennessee authorities within two weeks of any adverse or disciplinary action imposed against them.

Compounders producing sterile drugs also would be required to comply with guidelines set by the U.S. Pharmacopeia, a national standard-setting organization for pharmaceuticals.

Under one last-minute amendment adopted by the Senate, hospital pharmacies in Tennessee would be exempt from the requirement to file quarterly reports with the state detailing the volume of drugs they had produced.